FDA Initiates Albuterol Recall Over Mislabeling

A report released by the FDA on Monday announced the recall of mislabeled vials of Albuterol Sulfate Inhalation Solution.  The single-use, 2.5 mg/3 mL vials, produced by the Ritedose Corporation, “are embossed with the wrong concentration of 0.5 mg/3 mL and therefore, represents [sic] a potential significant health hazard,” says the FDA.

Though the foil overwrap pouches and shelf cartons display the correct concentration of the drug, the vials themselves bear incorrect labels which may lead doctors to mistakenly administer “5 times the recommended dose,” the report warns.  Because the outer layers of packaging are often removed when the vials are stocked in a hospital, the FDA claims it is likely that dosing errors could occur in this setting.

The Albuterol Sulfate solution is prescribed for both children and adults in the treatment of “acute asthma exacerbations and exercise induced asthma,” explains the FDA.  The drug is nebulized (aerosolized into a fine mist by a device called a nebulizer), then inhaled into the lungs. A CNN article about asthma lists albuterol among “rescue” or “quick-relief” asthma medications, which “are used as needed for rapid, short-term symptom relief during an asthma attack.”

An overdose could lead to albuterol toxicity, with symptoms the report lists as including “tremors, dizziness, nervousness, headache, seizures, angina, high blood pressure, low potassium levels, and rapid heart rates up to 200 beats [per] minute.”

The FDA advises consumers who have purchased the mislabeled vials to immediately return them to the doctor’s office, pharmacy, or other location where the drug was obtained.  Retailers and wholesalers who stock the solution “should return the product to the address stated in the firm Press Release,” says the report.   The press release also lists a phone number and e-mail address where customers can contact the Ritedose Corporation.

CNN’s asthma report outlines treatments for asthma, one of which is a group of “short-acting beta antagonists,” including albuterol.  These drugs are bronchiodilators, the report explains, and relieve sudden symptoms by helping to open the airways that bring oxygen into the lungs.  Though it may only take a few minutes for the beta-antagonists to take effect, the “effects last several hours,” says the article.

The FDA report explains the mislabeled product from the Ritedose Corporation “could result in a range of potential health effects that spans from temporary and medically reversible to life threatening and death.”


CNN staff writer. (March 27, 2010) “Occupational Asthma.” Retrieved on January 4, 2011 from CNN.

U.S. Food and Drug Administration. (January 3, 2011) “Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Unit Dose Vials: Recall – Mislabeled Unit Dose Vials.” Retrieved on January 4, 2011 from the FDA.